Aimovig And Tegsedi In Raft Of Products To Get EMA Thumbs up
Executive SummaryApproval applications for nine products received a positive opinion this week from the European Medicines Agency’s drug evaluation committee, the CHMP, and one product was turned down.
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Approved two months after Alnylam’s Onpattro, Tegsedi is priced almost identically in the same hATTR indication. Ionis affiliate Akcea hopes weekly subcutaneous administration will provide convenience benefit compared to I.V. Onpattro.
European approval is in the bag for Onpattro for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis but in a week where ICER has criticized the price of the RNAi drug in the US, Alnylam now has to navigate reimbursement talks on this side of the Atlantic.